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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P110013
Current Protocol Accepted 02/17/2012
Study Name OSB Lead-Resolute Integrity
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, multi-center, non- randomized, single-arm, open-label study.
Study Population Description Patients with de novo lesions in native coronary arteries that meet the eligibility criteria and   show the rest ...
Sample Size The observed event rate for the primary endpoints is assumed to be 2% at 12   show the rest ...
Data Collection Primary Endpoint

The primary endpoint for all patients enrolled in this study is the composite rate   show the rest ...
Followup Visits and Length of Followup The length of follow-up is 2 years.

Frequency of Follow-up Assessments: 30 days, 6 months,   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 230 subjects
Actual Number of Sites Enrolled Thirty sites enrolled in the study; however, one site did not enroll any study subjects   show the rest ...
Patient Followup Rate 94.8% (218/230)
Final Safety Findings Primary endpoint: Cardiac death (CD) and target vessel myocardial infarction (TVMI) at 12 months: 3.5%   show the rest ...
Final Effectiveness Findings Lesion Success1: 99.2% (243/245)

Device Success2: 99.2% (243/245)

Procedure Success3: 97.4% (221/227)

1 The attainment of < 30%   show the rest ...
Study Strengths and Weaknesses This study provides longer term (2 years) safety and effectiveness results of the Resolute Zotarolimus-   show the rest ...
Recommendations for Labeling Changes A labeling change is recommended to add a summary of the post-approval study results including   show the rest ...

OSB Lead-Resolute Integrity Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 08/17/2012 08/17/2012 On Time
one year report 02/16/2013 02/15/2013 On Time
18 month report 08/17/2013 08/16/2013 On Time
two year report 02/16/2014 02/18/2014 Overdue/Received
one year clinical report 10/03/2014 10/03/2014 On Time
Final Study Report 12/01/2015 09/30/2015 On Time

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